I received correspondence at the end of January from the Hon Catherine King MP stating:
'Non-sterile protective or safety apparel or equipment, for use in the home or for occupational or recreational use, has been declared not to be therapeutic goods. This declaration has been made under the Therapeutic Goods (Excluded Goods) Order No.1 of 2011. As per your example, bicycle helmets fall within this decription and therefore are not regulated by the Therapeutic Goods Administration under the Act.'
But yes, yes...I knew this which is why I asked in my letter to have the actual reason explained to me why bicycle helmets were not deemed to be therapeutic goods.
Inconsistency is evident on the Australian Register of Therapeutic Goods (ARTG) and appears to make a contrary case in that the Hon Catherine King's 'non-sterile protecitve or safety apparel or equipment, for use in the home or for occupational or recreational use' has been declared to be therapeutic goods...
But it seems to me that bicycle helmets have been disqualified as medical devices in order to cancel consent and refusal entitlements which would have automatically followed if bicycle helmets had been recognised as medical devices. Consequently a mini caveat has been slotted in at section 41BD(3) to provide a convenient little escape hatch for designated Secretary to be able to declare 'to be or not be' medical device proclamations even though designated Secretary may not even be a medical device expert.
It's all smoke & mirrors...as well as very flawed and very inconsistent and utterly contradictory.